DILIPO (DILutIonal HyPOnatremia)
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ClinicalTrials.gov Identifier: NCT00274326 |
Recruitment Status
:
Completed
First Posted
: January 10, 2006
Last Update Posted
: September 15, 2008
|
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Primary:
- To assess the efficacy of SR121463B in correcting hyponatremia in patients with dilutional hyponatremia other than SIADH or cirrhosis
Secondary:
- To assess the long-term efficacy of SR121463B in maintaining normonatremia in these patients
- To assess the safety and tolerability of SR121463B
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congestive Heart Failure | Drug: SR121463B | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of a Vasopressin V2 Receptor Antagonist (SR121463B) on Serum Sodium in Patients With Dilutional Hyponatremia |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | July 2007 |

- EFFICACY:Serum Sodium
- SAFETY:Physical examination, vital signs, adverse events, electrocardiogram, hematology, serum chemistry
- PHARMACOKINETICS:Plasma SR121463B concentrations
- Weight; EQ-5D and pharmaco-economic assessments

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or Female patients aged 18 higher
- Dilutional Hyponatremia with serum sodium between 115 and 132 mmol/L
- Ability to give written informed consent (the informed consent may be signed by a legally authorized representative if the patient is unable to sign)
Exclusion Criteria:
- Presence of known or untreated adrenal insufficiency, SIADH or cirrhosis, or hyperthyroidism
- Presence of signs of hypovolemia
- Administration of other V2 receptor antagonists or demeclocycline or lithium within one month and urea within two days prior to study drug administration
- Presence of uncontrolled diabetes with fasting glycemia ³ 200 mg/dL (³ 11.09 mmol/L)
- Patients considered by the Investigator unsuitable candidates to receive an investigational drug (e.g., presence of any neurological symptoms that may worsen in five days, based on the judgment of the Investigator, or presence of any neurological symptoms for which the persistence of hyponatremia over several days may be deleterious)
- Administration of inducers of CYP3A4 (phenobarbital, phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitors of CYP3A4 within two weeks prior to study drug administration
- Presence or history of allergic reaction to SR121463B8
- Previous study with SR121463B
- Inadequate hematological, renal, and hepatic functions: hemoglobin (Hb) < 9 g/dL, neutrophils < 1,500/mm3, platelets < 100,000/mm3, serum creatinine > 175 mol/L (or clearance of creatinine < 30 mL/min for sites where Ethics Committees require this parameter), serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN)
- QTCB 500 ³ ms
- Positive pregnancy test and absence of medically approved contraceptive methods (e.g., surgical sterilization of more than one month duration, oral contraception or intrauterine device in combination with either diaphragm, condom, or spermicide) for females of childbearing potential
- Pregnancy or breast-feeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274326
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina | |
Sanofi-Aventis Administrative Office | |
Buenos Aires, Argentina | |
Australia, New South Wales | |
sanofi-aventis Australia & New Zealand administrative office | |
Macquarie Park, New South Wales, Australia | |
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Canada | |
Sanofi-Aventis Administrative Office | |
Laval, Canada | |
Chile | |
Sanofi-Aventis Administrative Office | |
Santiago, Chile | |
Denmark | |
Sanofi-Aventis Administrative Office | |
Horsholm, Denmark | |
Greece | |
Sanofi-Aventis Administrative Office | |
Athens, Greece | |
Hungary | |
Sanofi-Aventis Administrative Office | |
Budapest, Hungary | |
Israel | |
Sanofi-Aventis Administrative Office | |
Natanya, Israel | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Portugal | |
Sanofi-Aventis Administrative Office | |
Porto Salvo, Portugal | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
South Africa | |
Sanofi-Aventis Administrative Office | |
Midrand, South Africa | |
Sweden | |
Sanofi-Aventis Administrative Office | |
Bromma, Sweden |
Study Chair: | Daniel Ter-Minassian, MD | Sanofi |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00274326 History of Changes |
Other Study ID Numbers: |
EFC5816 |
First Posted: | January 10, 2006 Key Record Dates |
Last Update Posted: | September 15, 2008 |
Last Verified: | September 2008 |
Keywords provided by Sanofi:
Hyponatremia |
Additional relevant MeSH terms:
Heart Failure Hyponatremia Heart Diseases Cardiovascular Diseases Water-Electrolyte Imbalance Metabolic Diseases |
Satavaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |